Dry vs Wet Misoprostol for Cervical Dilation in First Trimester Abortion - A Clinical Trial
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 46
- Locations
- 1
- Primary Endpoint
- Cervical dilation
Study Overview
Brief Summary
This study aims to verify whether the moisture of 400 µg of misoprostol pre uterine evacuation increases the dilatation of uterine cervix compared to dry misoprostol
Detailed Description
Misoprostol is the most widely used drug for abortion due to its low cost, stability and easy to use regimen. Nevertheless, there is a debate whether the administration of dry misoprostol has similar effects compared to wet pill. It would be necessary to undertake a clinical trial to evaluate which regimen (dry or wet) offers a better cervical dilation pre uterine evacuation. The primary objective of this study is to compare the degree of cervical dilatation pre-uterine evacuation in subject that received 400 µg of dry or wet misoprostol 3 or more hours before the procedure. Secondary objective is to verify whether there is a correlation between vaginal pH (<5 / ≥5) and the degree of cervical dilation (≥8mm / <8mm) with the use of wet or dry misoprostol. Women will be randomized to one of the two groups: dry or wet misoprostol.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 14 Years to 50 Years (Child, Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Women with abortion (less than 12 weeks of pregnancy)
Exclusion Criteria
- •congestive heart failure
- •chronic pulmonary disease
- •hypovolemic shock
- •Marfan syndrome
- •septic abortion (fever, pus , leukocytosis >14,000)
- •known allergies to misoprostol
- •blood dyscrasia
- •open cervical (≥ 1cm)
- •use of intrauterine device
Arms & Interventions
Dry Misoprostol
400 µg of dry misoprostol
Intervention: dry misoprostol (Drug)
Wet misoprostol
400 µg of wet misoprostol
Intervention: wet misoprostol (Drug)
Outcomes
Primary Outcomes
Cervical dilation
Time Frame: 3 to 4 hours after putting misoprostol into the vagina
Cervical dilation will be measure with Karman cannulas
Secondary Outcomes
- Vaginal acidity - hydrogen ion concentration(within 2 min before putting the misoprostol into the vagina)